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On September 6, FDA released a white paper titled “Strengthening Our National System for Medical Device Postmarket Surveillance.” This paper stems at least in part from the recommendation by the Institute of Medicine for FDA to “develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze, and act on medical device postmarket performance information.”

The paper proposes the following four actions to strengthen the medical device postmarket surveillance system:

Establish a unique device identification ("UDI") system and promote its incorporation into electronic health information;

Promote the development of national and international device registries for selected products;

Modernize adverse event reporting and analysis; and

Develop and use new methods for evidence generation, synthesis and appraisal.

UDI. In July 2012, FDA issued a proposed rule for implementing a UDI system. UDIs are intended to enhance postmarket surveillance “by providing a standard and unambiguous way to document device use in [electronic health records], clinical information systems, and claims data sources.” This information may then be used to assess the benefits and risks of medical devices, and will allow FDA and industry to report and analyze device-related adverse events by ensuring that necessary information is included in the adverse event reports. The UDIs will also help healthcare professionals track devices through the supply chain to point of care in the event of a recall or medical error.

Development of national and international registries. The paper states that FDA is not seeking to develop a centralized repository of registry data, but rather is encouraging the development of registries that “contain sufficiently detailed patient, device and procedural data” that are “linked to meaningful clinical outcomes.”

FDA acknowledges that it is not feasible to have a registry addressing every medical device problem or issue. It therefore suggests that, rather than designing registries for a particular manufacturer or product, it would be “more cost-effective to pursue nationwide medical device registries focused on certain product areas of high importance.” This would be determined by issues of public health need, patient exposure, real-world performance, or societal cost. The paper states that for device areas “where the benefit-risk profiles are well-understood, registries may not be needed.” To determine the areas for which registries should be developed, FDA will convene registry experts and key stakeholders to discuss how registries might best contribute to postmarket surveillance efforts.

Modernize adverse event reporting and analysis. The paper states that FDA will be seeking ways to automate adverse event reporting to “facilitate the submission of device-related adverse events and minimize the effort required by the reporter.” CDRH is currently piloting an automated system, the Adverse Spontaneous Triggered Events Reporting (ASTER) system, to “detect and automatically report select device associated adverse events” to FDA. FDA hopes that automated reporting will increase the number and quality of adverse events reported.

FDA also plans to take the following steps to improve adverse event reporting:

Increase the amount of MDRs reported electronically;

Develop a mobile application for adverse event reporting;

Develop a new system, the FDA Adverse Event Reporting System (FAERS), with “expanded capacity and modern analytic capability for identifying and extracting relevant information in automated fashion”; and

Explore use of safety signals to systematically prioritize MDRs for evaluation and review.

Develop methods for evidence generation. The final step identified by FDA for improving postmarket surveillance is the “development of new tools and methods to generate, synthesize, and interpret postmarket information” to “improve the efficiency and quality of decision-making.” To do so, FDA proposes the following:

Use of quantitative decision analysis to help evaluate benefits and risks of medical devices;

Use safety signals to identify unwanted or unexpected effects associated with a product.

The paper leaves unanswered several important questions, such as how FDA will use the extensive information gained from the expanded postmarket surveillance program, how it will affect premarket requirements, and how would it be used in regulating products that are on the market.

The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.

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